None listed
Conditions
Brief summary
Most newborn infants less than 30 weeks' gestational age at birth require either nasal continuous positive airway pressure (nCPAP) or intubation and mechanical ventilation for acute respiratory distress syndrome at the point of delivery, whether in the delivery suite or in the operating theatre. This is an interventional study looking at whether using a targeted expiratory tidal volume mode of ventilation from the point of delivery until admission in the neonatal intensive care unit may improve a newborn infant's blood gas parameters on arrival in the neonatal intensive care unit. Monitoring and adjusting ventilation to achieve normal arterial carbon dioxide levels is standard practice once the baby is within the neonatal intensive care unit. Current best practice recommends using handbagging ventilation or intermittent mandatory ventilation (IMV); volumes of each breath are not usually measured until the newborn is connected to a ventilator in the neonatal intensive vare unit . The use of an advanced neonatal ventilator which can target set expiratory tidal volumes in the resuscitation, stabilisation and transport of such a premature neonate may allow better arterial blood gases on arrival to the neonatal intensive care unit. Further, the impact of the use of an advanced neonatal ventilator from point of delivery may influence the initial respiratory course as well as the cerebrovascular circulation. This randomised controlled trial (RCT) may demonstrate the value of using an advanced neonatal ventilator in the initial ventilatory management of critically ill newborn babies.
Interventions
Triggered, volume-targeted mechanical ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit. Ventilator set to target an exhaled tidal volume of 5 mL/kg with inspiratory pressures automatically adjusted breath-to-breath by the ventilator depending on pulmonary compliance. Cerebral oxygenation monitoring using spatially resolved near infra-red spectroscopy in the first 48 hours of life; ultrasound assessment of cardiac output and pr
Triggered, volume-targeted mechanical ventilation (for those newborns that require ventilation) from the delivery suite to the neonatal intensive care unit. Ventilator set to target an exhaled tidal volume of 5 mL/kg with inspiratory pressures automatically adjusted breath-to-breath by the ventilator depending on pulmonary compliance. Cerebral oxygenation monitoring using spatially resolved near infra-red spectroscopy in the first 48 hours of life; ultrasound assessment of cardiac output and presence of a patent ductus arteriosus in the first 48 hours of life.
Sponsors
Dr Mark Tracy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
23 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
Preterm babies less than 30 weeks’ gestation at birth
Exclusion criteria
Suspected pulmonary hypoplasia, suspected chromosomal abnormality or a suspected syndrome.
Outcome results
None listed